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EP3290432A4 - High performance liquid chromatography method for polypeptide mixtures - Google Patents

High performance liquid chromatography method for polypeptide mixtures Download PDF

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Publication number
EP3290432A4
EP3290432A4 EP15890235.3A EP15890235A EP3290432A4 EP 3290432 A4 EP3290432 A4 EP 3290432A4 EP 15890235 A EP15890235 A EP 15890235A EP 3290432 A4 EP3290432 A4 EP 3290432A4
Authority
EP
European Patent Office
Prior art keywords
high performance
liquid chromatography
performance liquid
chromatography method
polypeptide mixtures
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP15890235.3A
Other languages
German (de)
French (fr)
Other versions
EP3290432B1 (en
EP3290432A1 (en
Inventor
Yangming TANG
Gang He
Guotao LI
Anjin TAO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hybio Pharmaceutical Co Ltd
Original Assignee
Hybio Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hybio Pharmaceutical Co Ltd filed Critical Hybio Pharmaceutical Co Ltd
Priority to EP19198022.6A priority Critical patent/EP3613756B1/en
Priority to EP19198009.3A priority patent/EP3603764B1/en
Publication of EP3290432A1 publication Critical patent/EP3290432A1/en
Publication of EP3290432A4 publication Critical patent/EP3290432A4/en
Application granted granted Critical
Publication of EP3290432B1 publication Critical patent/EP3290432B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/26Conditioning of the fluid carrier; Flow patterns
    • G01N30/28Control of physical parameters of the fluid carrier
    • G01N30/34Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/16Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166Fluid composition conditioning, e.g. gradient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/03Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/32Bonded phase chromatography
    • B01D15/325Reversed phase
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/362Cation-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/363Anion-exchange
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/33Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/62Detectors specially adapted therefor
    • G01N30/74Optical detectors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/86Signal analysis
    • G01N30/8624Detection of slopes or peaks; baseline correction
    • G01N30/8631Peaks
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803General methods of protein analysis not limited to specific proteins or families of proteins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/20Partition-, reverse-phase or hydrophobic interaction chromatography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Food Science & Technology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Psychiatry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hospice & Palliative Care (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
EP15890235.3A 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures Active EP3290432B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP19198022.6A EP3613756B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures
EP19198009.3A EP3603764B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2015/077690 WO2016172855A1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures

Related Child Applications (4)

Application Number Title Priority Date Filing Date
EP19198022.6A Division-Into EP3613756B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures
EP19198022.6A Division EP3613756B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures
EP19198009.3A Division EP3603764B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures
EP19198009.3A Division-Into EP3603764B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures

Publications (3)

Publication Number Publication Date
EP3290432A1 EP3290432A1 (en) 2018-03-07
EP3290432A4 true EP3290432A4 (en) 2019-03-27
EP3290432B1 EP3290432B1 (en) 2022-03-30

Family

ID=57198918

Family Applications (3)

Application Number Title Priority Date Filing Date
EP19198022.6A Active EP3613756B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures
EP19198009.3A Active EP3603764B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures
EP15890235.3A Active EP3290432B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EP19198022.6A Active EP3613756B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures
EP19198009.3A Active EP3603764B1 (en) 2015-04-28 2015-04-28 High performance liquid chromatography method for polypeptide mixtures

Country Status (5)

Country Link
US (1) US10330650B2 (en)
EP (3) EP3613756B1 (en)
JP (1) JP6676072B2 (en)
CN (3) CN112649537B (en)
WO (1) WO2016172855A1 (en)

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CN111060635A (en) * 2019-11-27 2020-04-24 吉尔生化(上海)有限公司 Analysis and detection method of carbetocin
CN111138516B (en) * 2020-01-10 2023-04-25 大理大学 A kind of Vespa peptide and its preparation method and application
CN112858522B (en) * 2021-02-20 2022-09-20 重庆工贸职业技术学院 A method for separation and determination of heteroamino acids in high-purity valine by high performance liquid chromatography
CN113009014B (en) * 2021-02-24 2023-04-07 上海旭东海普药业有限公司 High performance liquid detection method for 2-methoxy-5-fluorouracil impurities
CN113720941B (en) * 2021-09-18 2023-03-24 广东丸美生物技术股份有限公司 Detection method of polypeptide in skin care product raw material or skin care product and high performance liquid chromatography detection method of polypeptide
CN114280179B (en) * 2021-12-22 2024-03-15 北京美福润医药科技股份有限公司 Pretreatment of exenatide and detection method of isomer in His amino acid eluent obtained by pretreatment
CN114384194B (en) * 2021-12-28 2023-09-22 湖南中晟全肽生化有限公司 Method for high-flux detection of polypeptide
CN114609286A (en) * 2022-03-18 2022-06-10 浙江理工大学 A kind of method for detecting isophthalic acid content of polyester fabric
KR102742623B1 (en) * 2022-04-07 2024-12-16 에쓰대시오일 주식회사 Method and device for measuring the amount of rubber in impact polypropylene
CN115078592B (en) * 2022-07-15 2024-01-23 广东广纳安疗科技有限公司 Detection method of acrylamide monomer and application thereof
CN115586288B (en) * 2022-10-08 2024-07-26 广州朗圣药业有限公司 High performance liquid chromatography detection method for SZFZ-A content in SZFZ-A-containing composition
CN115656391B (en) * 2022-12-12 2023-04-07 哈尔滨吉象隆生物技术有限公司 Method for detecting impurities contained in teriparatide
CN116429950B (en) * 2023-06-07 2023-08-11 成都佩德生物医药有限公司 Method for analyzing related substances of polypeptide PD-DP-005

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Also Published As

Publication number Publication date
CN107531750A (en) 2018-01-02
EP3603764B1 (en) 2022-03-30
CN112649537B (en) 2024-03-29
EP3290432B1 (en) 2022-03-30
CN112649538A (en) 2021-04-13
EP3603764A1 (en) 2020-02-05
EP3290432A1 (en) 2018-03-07
JP2018515766A (en) 2018-06-14
EP3613756A1 (en) 2020-02-26
EP3613756B1 (en) 2024-02-21
CN112649537A (en) 2021-04-13
CN107531750B (en) 2021-03-16
WO2016172855A1 (en) 2016-11-03
JP6676072B2 (en) 2020-04-08
US10330650B2 (en) 2019-06-25
CN112649538B (en) 2024-03-29
US20180080909A1 (en) 2018-03-22

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